SBV2, MULTICHARGER MODEL MC10V2


Device Classification Name

device, sleep assessment

510(k) Number K111514
Device Name SBV2, MULTICHARGER MODEL MC10V2
Applicant
SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE
5405 alton parkway
suite a530
irvine, 
CA 
92604

Applicant Contact marc goodman
Correspondent
SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE
5405 alton parkway
suite a530
irvine, 
CA 
92604

Correspodent Contact marc goodman
Classification Product Code
LEL  
Date Received 06/01/2011
Decision Date 12/16/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No